Table 3

Summary of assessment type, completers and timing

AssessmentWho to complete/actionTimeline (weeks post-randomisation)
ScreeningBaselineWeek 6Week 12
Baseline data (collected from case notes)
 Demographic data, eligibility, written informed consentResearch nurseX
 Background and medical historyResearch nurseX
 Referral to local participating community palliative care teamResearch nurseX
 Schedule initial appointment within 1 week; deliver usual care OR usual care and introduction of trial interventions as determined by randomisation allocationPalliative care teamX
Clinical follow-up data (collected from case notes or hospice system for example, SystmOne)
 Use of Intervention and usual care detailsPalliative care teamX
 All-cause mortalityPalliative care teamX
 Serious adverse event reportingPalliative care teamOngoing reporting
Clinical follow-up data (collected from case notes, hospital system for example, SystmOne and PPM database)
 Healthcare useResearch nurseX
 Pain medicationResearch nurseXX
 Date of referral to community palliative care, no and details of contactsResearch nurseX
 All-cause mortalityResearch nurseX
 Serious adverse event reportingResearch nurseOngoing reporting
Patient-completed questionnaires (completed in clinic at baseline and at home/over telephone for follow-up visits)
 BPI assessmentTrial researcherXXX
 7-point global rating change of painTrial researcherXX
 Healthcare use (Health Economics questionnaire)Trial researcherXXX
 Patient Pain Questionnaire40 Trial researcherXXX
 EQ-5D41 Trial researcherXXX
 EORTC QLQ-C3042 Trial researcherXXX
Clinical follow-up data (collected via GP practice)
 Date of referral to community palliative careTrial researcherOngoing reporting
 Survival statusTrial researcher/Leeds Institute of Clinical Trials ResearchOngoing reporting
Routine monitoring data
 Uptake (patients and palliative care nurse) and patient-reported pain diariesTrial researcher*Ongoing reporting
 Qualitative participant interviewsTrial researcher*~6 or 12 weeks post-randomisation
 Participant qualitative palliative care nurse end of trial interviewsTrial researcher*End of trial
  • *Conducted through a different trial researcher involved in patient-completed questionnaire follow-up and clinical follow-up.

  • BPI, Brief Pain Inventory; EORTC, European Organization for Research and Treatment of Cancer; GP, general practitioner.